Regulatory Support for Software in Medical Devices Including ML and AI-Enabled Devices

Expertise in EU and FDA Compliance for Medical Device Software

Our regulatory support for medical device software provides specialized expertise to navigate the complex regulatory landscape. With extensive experience in FDA and EU regulations, our team offers comprehensive support to ensure your software, including Artificial Intelligence (AI) and Machine Learning (ML) components, meets stringent regulatory requirements. Our expert team supports you through:

• SaMD and SiMD regulatory strategy and submission preparation
• IFU and labeling review and consultation
• Design control procedures and training
• Marketing submissions for software functions
• Predetermined change control plan
• Good Machine Learning Practice incorporation into design control and QMS
• Cybersecurity requirements
• Human factors and usability testing
• Software verification and validation testing
• SBOM (Software Bill of Materials)
• Clinical validation and clinical evaluation

How NAMSA Can Assist with SaMD and SiMD Compliance

NAMSA can help you with clinical and regulatory strategy, and compile marketing submissions for any standalone or embedded medical device software regulated by the US FDA, EU MDR, or IVDR.  From initial concept through to market approval, we can assist in identifying applicable regulations, defining your regulatory pathway, and preparing detailed documentation to support your submission.

NAMSA support does not end with market approval. We can also help you:

• Achieve favorable payer coverage determinates and establish a base of clinical evidence to encourage adoption of your product.
• Assist with ongoing post-market surveillance services to monitor the performance of your software in the field.
• Help you establish systems for tracking and reporting adverse events, conducting periodic reviews, and implementing necessary updates to maintain compliance.

Our continuous improvement approach ensures that your software remains safe, effective, and compliant throughout its lifecycle.

Examples of Medical Device Software

Strategy and Support for AI Medical Devices Sold in the US or Europe

If your medical device includes software that is enabled by artificial intelligence (AI), NAMSA can help you comply with the European AI Act and US FDA requirements.

European AI Act Requirements Support

The European AI Act introduces stringent requirements for AI systems, particularly those used in medical devices. NAMSA provides comprehensive support to ensure your AI-enabled device meets these regulations. Most devices in the scope of the MDR and IVDR will be considered high-risk AI models. They will be subject to conformity assessments by Notified Bodies certified to audit devices that incorporate Artificial Intelligence.  We assist in classifying your AI system according to the risk categories defined by the AI Act and developing a robust risk management plan. NAMSA can also assist with QMS, vigilance and cybersecurity requirements relating to the AI Act as well as helping with the interaction between the MDR/IVDR and the AI Act to avoid possible confusion and duplication.

US FDA AI Requirements Support

For the US market, NAMSA provides specialized support to navigate the FDA’s evolving requirements for AI-enabled medical devices. We assist in developing a pre-submission strategy to engage with the FDA early in the development process, ensuring that your AI device meets regulatory expectations. Our team can help you establish and submit to FDA Predetermined Change Control Plans for managing changes to your AI algorithms, ensuring continuous compliance with FDA requirements. We also support the postmarket collection and analysis of real-world evidence to demonstrate the ongoing safety and effectiveness of your AI device, and comply with Good Machine Learning Practices.